Status:
WITHDRAWN
L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Conditions:
End Stage Renal Disease
Hemodialysis
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
Cardiovascular disease is the primary cause of death in patients with end stage renal disease (ESRD). New research suggests that the high risk of death may be partly due to high levels of fibrosis and...
Detailed Description
We hypothesize that that abnormalities in aldosterone and nitric oxide (NO) homeostasis contribute to the progression of microvascular disease and myocardial fibrosis in ESRD and that agents designed ...
Eligibility Criteria
Inclusion
- Chronic dialysis therapy for End Stage Renal Disease
- Age 21-85
Exclusion
- Hyperkalemia requiring unscheduled dialysis within 3 months
- Pre-dialysis potassium ≥6.5 meq/L within 3 months
- Hypotension defined as SBP \<100
- Recurrent intra-dialytic hypotension defined as recurrent cramping, light-headedness, or hypotension requiring infusion of saline or other intervention or otherwise limiting ability to achieve dry weight. Or SBP \<80
- History of myocardial infarction
- History of coronary artery bypass surgery
- Non revascularized coronary disease \>90%
- Mitral valve repair or replacement
- Severe mitral valve disease
- Renal transplant expected within 9 months
- Expected survival \< 9 months
- Pregnant
- Prisoners
- Unable to provide consent
- Allergy to spironolactone or L-arginine
- Digitalis use
- 1st or 2nd degree heart block
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01855334
Start Date
September 1 2013
End Date
July 1 2018
Last Update
May 4 2017
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 021114
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02120
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215